Triathlon 5537-G-511Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327027297), received between Feb 5, 2018 and Jul 28, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A 5X11 TS INSERT WAS REVISED TO A 5X11 PS INSERT (REP REPORTED THE REASON FOR THE CHANGE IN THE TYPE OF LINER WAS DUE TO THE SURGEON WANTING A LESS CONSTRAINED OPTION FOR THE LINER AS THE PATIENT'S SOFT TISSUE HEALED WELL).

  Patient problems: Unspecified Infection

  MAUDE report 15126286 ↗
• InjurySep 2, 2021Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT'S WIFE, PATIENT HAD A RIGHT TKA ON 2010 (APPROX). WITHIN A YEAR OF THE SURGERY PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING. THE PATIENT FOLLOWED UP WITH HIS SURGEON AND WAS TOLD HE HAD AN INFECTION AND WAS REVISED ON 2012 (APPROX). THE PATIENT WAS IMPLANTED WITH AN ANTIBIOTIC SPACER AND APPROX 3-5 MONTHS LATER THE PATIENT WAS IMPLANTED. EARLY THIS YEAR THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6) 2021 THE PATIENT FOLLOWED UP WITH HIS SURGEON WHERE AN X-RAY WAS TAKEN AND WAS TOLD THAT HIS IMPLANT WAS CRACKED. THE SURGEON RECOMMENDED REVISION. PATIENT WOULD LIKE SOME ASSISTANCE WITH MEDICAL BILLS AND REVISION SURGERY. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR REVISION OF PRIMARY DUE TO INFECTION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 12413548 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF TRIATHLON TS RIGHT TOTAL KNEE ARTHROPLASTY DUE TO INFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 11398690 ↗
• InjuryOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2019. PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2014. PATIENT UNDERWENT RIGHT REVISION (B)(6) 2014 FOR PJI. PATIENT HAD SPACER EXPLANT AND HINGED KNEE REPLACEMENT WITH EXTENSOR MECHANISM ALLOGRAFT (B)(6) 2019. UPDATE: THE PREVIOUS REVISION FOR INFECTION (B)(6) 2014 WAS A POLY EXCHANGE. NO CONFIRMATION OF SPACER IMPLANTATION OR REMOVAL SO (B)(6) 2019 NOT AN ANTICIPATED 2ND STAGE.

  Patient problems: Injury

  MAUDE report 9213430 ↗
• MalfunctionOct 22, 2018Difficult to Insert; Difficult to Insert

  DURING A REVISION OF PATIENT'S LEFT KNEE, A 5X11 TS INSERT WAS IMPLANTED AND REMOVED BECAUSE THE LOCKING MECHANISM WAS COMPROMISED. REP REPORTED THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7991655 ↗
• InjuryJun 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY REP: "PATIENT UNDERWENT A REPAIR OF DAMAGED [RIGHT] PATELLA TENDON. X3 INSERT WAS SWAPPED OUT AS PART OF 'WASH OUT'".

  Patient problems: Injury; Tissue Damage; Unspecified Infection

  MAUDE report 7626707 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DR. (B)(6) AT HOSPITAL (B)(6) PERFORMED AN ABOVE THE KNEE AMPUTATION OF THE RIGHT LEG ON A PATIENT WITH AN INFECTED STRYKER TRIATHLON REVISION TOTAL KNEE. THE HISTORY OF THE PATIENT INCLUDED A RIGHT MEDIAL UNICOMPARTMENTAL KNEE IN (B)(6) 2011 (PER OP NOTES: DR. (B)(6) OP NOTE MADE MENTION OF IT BEING A MAKOPLASTY, HOWEVER DR. (B)(6) AND HOSPITAL (B)(6) DIDN'T HAVE THE MAKO TECHNOLOGY AT THAT TIME) POSSIBLY WITH DR. (B)(6) AT HOSPITAL (B)(6). THEN THE PATIENT WAS INFECTED AND HAD AT LEAST ONE OR POSSIBLY TWO KNEE REVISIONS (IMPLANT SYSTEM UNKNOWN) BEFORE VISITING WITH DR. (B)(6) OF HOSPITAL (B)(6). DR. (B)(6) HAD REMOVED THE TOTAL KNEE IMPLANTS AND PUT A CEMENT SPACER IN SOME TIME IN 2016. HE THEN PERFORMED THE 2ND STAGE REVISION ON (B)(6) 2016 IMPLANTING STRYKER TRIATHLON REVISION IMPLANTS. ACCORDING TO DR. (B)(6) SOME MONTHS FOLLOWING THAT SURGERY, THE PATIENT BECAME INFECTED ONCE AGAIN WHICH HAS LED TO THE PROCEDURE TODAY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7242510 ↗